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Therapeutic effectiveness of the left bundle branch pacing evaluated by speckle tracking automated functional imaging

Clinical research on left bundle branch area pacing and cardiac resynchronization therapy using automatic functional imaging technology

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110771
Enrollment
Unknown
Registered
2025-10-20
Start date
2020-03-01
Completion date
Unknown
Last updated
2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-grade atrioventricular block

Interventions

Health Volunteer Group :None
RVSP Group:Implantation of a right ventricular septal pacemaker
LBBP Group:Implantation of a left bundle branch pacemaker
Lot-CRT Group:Implant left bundle branch to optimize CRT
BiV-CRT group:Implantation of traditional dual-chamber pacemaker CRT

Sponsors

Guizhou Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Trial One: (1) All biochemical indicators from the physical examination are within the normal range, and the results of the electrocardiogram and imaging examinations are normal; (2) No history of chronic diseases such as hypertension, diabetes, pulmonary heart disease, or renal insufficiency; (3) No history of long-term medication use; (4) The patient and the patient's family have signed the informed consent form and have agreed to participate in this study. 2. Trial Two: (1) Electrocardiogram indicates patients with high-degree or third-degree AV block (III°AVB); (2) Age >= 18 years; (3) LVEF: males >= 52%, females >= 54%; (4) No past or current clinical manifestations of heart failure; (5) First-time implantation of a pacemaker; (6) Pacemaker follow-up programming indicates ventricular pacing dependence (pacing percentage >40%); (7) The patient and the patient's family have signed the informed consent form and agreed to participate in this study. 3. Trial Three: (1) Meets the Class I, IIa, or IIb indications for CRT implantation according to the 2013 EHRA/ESC Guidelines on Cardiac Pacing and Cardiac Resynchronization Therapy; (2) After 3 to 6 months of treatment with scientifically optimized maximum tolerated doses of heart failure medications such as ACE inhibitors/ARBs, diuretics, aldosterone receptor antagonists, beta-blockers, sacubitril/valsartan, and ivabradine, heart failure symptoms still recur; (3) The patient and the patient's family are fully informed, voluntarily agree to participate in this study, and have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Trial 1: (1) Male LVEF =45mm; (6) Cirrhosis, bilirubin elevated 2-fold, or AST/ALT/ALP elevated 3-fold; (7) Long-term dialysis, kidney transplantation, or chronic kidney disease with serum creatinine >200 µmol/L; (8) Poor ultrasound image quality due to obesity, being underweight, hyperinflated lungs, or other reasons; 3. Trial 3: (1) Combined long-term dialysis, kidney transplantation, or chronic kidney disease with serum creatinine >200 µmol/L; (2) Combined cirrhosis, bilirubin elevated 2-fold, or AST/ALT/ALP elevated 3-fold; (3) Combined severe pulmonary heart disease with right ventricular basal diameter >=45mm; (4) Combined psychiatric disorders and severe neurological diseases; (5) Combined malignant tumors; (6) Contraindications for CRT/CRT-D therapy; (7) Poor ultrasound image quality due to obesity, being underweight, hyperinflated lungs, or other reasons.

Design outcomes

Primary

MeasureTime frame
Echocardiography image;6 minute walking distance test, 6-MWT;Peak strain dispersion, PSD;Left ventricular global longitudinal strain ,GLS;Left ventricular global work index,GWI;Global constructive work,GCW;Global waste work,GWW;Global work efficiency,GWE;left ventricular ejection fraction ,LVEF;Left ventricular end-diastolic diameter,LVEDD;Left atrium diameter,LAd;

Secondary

MeasureTime frame
Width of the QRS wave in electrocardiogram ;

Countries

China

Contacts

Public ContactTan Jing

Guizhou Provincial People's Hospital

tanjingecho@qq.com+86 193 8551 3459

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026